Effects of Cognitive Behavioural Therapy and Exercise on Stress and Cognitive Deficits in Multiple Sclerosis
Primary Purpose
Multiple Sclerosis, Cognitive Deficits, Stress, Psychological
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy
Aerobic Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Stress, Psychological, Psychological Stress, Emotional Stress, Cognitive Deficits, Cognitive Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of relapse-remitting MS according to the McDonald criteria
- General Health Questionnaire short form (GHQ-12) score of ≥2
- Extended Disability Status Scale (EDSS) score of ≤5
- Physical Activity Readiness Questionnaire (PAR-Q) score of ≤1
Exclusion Criteria:
- Any past history of traumatic brain injury, psychotic mental illness, developmental delay, substance abuse (excluding cannabis) and systemic illness
- Current (last 6 months) participation in an exercise regimen of moderate-strenuous intensity, greater than 2 days a week
- Incapable of providing informed consent
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Aerobic Exercise
CBT and Aerobic Exercise
Waitlist Condition
Arm Description
12-week structured and monitored aerobic exercise program
Combined 12-week individual Cognitive Behavioural Therapy and Exercise Program
12-week waitlist control condition, after which participants will have the chance to receive CBT group treatment.
Outcomes
Primary Outcome Measures
Change from Baseline in General Health Questionnaire (GHQ-28) at 12 Weeks
The GHQ-28 is a 28-item self-report used to psychological stress. The GHQ focuses on two main classes of phenomena: 1) inability to carry out one's normal healthy functions; and 2) emergence of new phenomena that are distressing.
Secondary Outcome Measures
Change from Baseline in the Minimal Assessment of Cognitive Function in MS at 12 Weeks
The Minimal Assessment of Cognitive Function in MS (MACFIMS)is a 90 minute cognitive battery comprised of seven tests covering five cognitive domains commonly impaired in MS (processing speed/working memory; learning and memory; executive function; visuo-spatial processing; word retrieval).
Full Information
NCT ID
NCT01763983
First Posted
January 7, 2013
Last Updated
October 14, 2016
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Multiple Sclerosis Society of Canada
1. Study Identification
Unique Protocol Identification Number
NCT01763983
Brief Title
Effects of Cognitive Behavioural Therapy and Exercise on Stress and Cognitive Deficits in Multiple Sclerosis
Official Title
A Randomized Controlled Trial Testing the Additive Benefits of CBT and Exercise For Psychological Stress and Cognitive Dysfunction in MS
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Multiple Sclerosis Society of Canada
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
High levels of psychological stress have been reported by 90% of patients with MS experiencing disease exacerbation, and approximately 39% of those with more stable disease course. These stress levels are comparable to patients with a clinical diagnosis of major depression. Cognitive dysfunction affects approximately 40% of community surveyed MS patients, and stress may exacerbate the cognitive burden. Studies have shown that Cognitive Behavior Therapy (CBT) is effective in treating psychological stress. Studies have also shown that exercise is beneficial to mood and cognitive function. Therefore the proposed study will test the comparative benefits of combining CBT and Exercise as an intervention for stress and cognitive dysfunction in MS subjects. The 2 active treatment conditions will be compared with a waitlist control condition.
There are 4 broad aims to this study: 1) to compare the relative efficacy of CBT, Exercise, and CBT-Exercise for stress in MS, 2) to examine the extent to which neuropsychological features of stress and MS, especially working memory and executive functioning, improve following treatments, 3) to determine the extent to which neuropsychological factors are associated with successful treatment response and improved quality of life, and 4) to determine if combined CBT-Exercise confers greater benefits on measures of stress and neuropsychological functioning compared with Exercise alone.
The study hypotheses are: 1) All active treatment conditions will lead to significantly greater improvement on measures of stress at post-treatment and follow-up compared to waitlist controls, 2) Combined CBT-Exercise will lead to comparatively greater symptom reduction compared to all other conditions at post-treatment and follow-up assessments on measures of stress, 3) All active treatment conditions will lead to significant improvement in neuropsychological functioning (particularly measures of working memory and executive functioning) at post-treatment compared to controls, and 4) Combined CBT-Exercise will lead to greater improvement in neuropsychological functioning compared to all other conditions at post-treatment.
The study design allows for examination of the potential additive benefits of CBT and Exercise to usual therapy for patients, and its feasibility as a viable treatment model for MS outpatient clinics and community-based intervention programs. This study will shed light on the treatment of sub-threshold symptoms that are strikingly common in MS population, but often overlooked in favour of more concrete diagnoses (e.g. major depression disorder). This proposed study will also be the first to determine whether evidence-based non-medical treatments for stress and mood disturbances in MS reduce underlying cognitive substrates associated with the illness and known to be exacerbated by stress.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Cognitive Deficits, Stress, Psychological
Keywords
Multiple Sclerosis, Stress, Psychological, Psychological Stress, Emotional Stress, Cognitive Deficits, Cognitive Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
173 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic Exercise
Arm Type
Experimental
Arm Description
12-week structured and monitored aerobic exercise program
Arm Title
CBT and Aerobic Exercise
Arm Type
Experimental
Arm Description
Combined 12-week individual Cognitive Behavioural Therapy and Exercise Program
Arm Title
Waitlist Condition
Arm Type
No Intervention
Arm Description
12-week waitlist control condition, after which participants will have the chance to receive CBT group treatment.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy
Other Intervention Name(s)
CBT
Intervention Description
CBT will be delivered individually, 1 hour per week, for 12 consecutive weeks. CBT for stress in MS is a structured, short-term, present-oriented therapy with an emphasis on problem-solving and the modification of dysfunctional thinking and behaving. Cognitive strategies include the use of dysfunctional thought records for recording and challenging negative automatic thoughts and the use of behavioural strategies to increase involvement and commitment to personal goals.
Group therapy following a similar protocol (2 hrs/week) will be offered to those in the waitlist condition after completing the study.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise
Intervention Description
Aerobic exercise will occur three times per week at participating gyms. Duration of the exercise periods will be 15-30 minutes for the first 4 weeks (training stage) and 30-45 minutes for the remaining 8 weeks (improvement stage). The exercise regimen will progress from light-moderate exercise (40-60% intensity) to moderate-high exercise (60-80% intensity), following the same course as the increase in duration.
Primary Outcome Measure Information:
Title
Change from Baseline in General Health Questionnaire (GHQ-28) at 12 Weeks
Description
The GHQ-28 is a 28-item self-report used to psychological stress. The GHQ focuses on two main classes of phenomena: 1) inability to carry out one's normal healthy functions; and 2) emergence of new phenomena that are distressing.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in the Minimal Assessment of Cognitive Function in MS at 12 Weeks
Description
The Minimal Assessment of Cognitive Function in MS (MACFIMS)is a 90 minute cognitive battery comprised of seven tests covering five cognitive domains commonly impaired in MS (processing speed/working memory; learning and memory; executive function; visuo-spatial processing; word retrieval).
Time Frame
Baseline and 12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of relapse-remitting MS according to the McDonald criteria
General Health Questionnaire short form (GHQ-12) score of ≥2
Extended Disability Status Scale (EDSS) score of ≤5
Physical Activity Readiness Questionnaire (PAR-Q) score of ≤1
Exclusion Criteria:
Any past history of traumatic brain injury, psychotic mental illness, developmental delay, substance abuse (excluding cannabis) and systemic illness
Current (last 6 months) participation in an exercise regimen of moderate-strenuous intensity, greater than 2 days a week
Incapable of providing informed consent
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Effects of Cognitive Behavioural Therapy and Exercise on Stress and Cognitive Deficits in Multiple Sclerosis
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